Brevoxyl 4% Cream

1. Name Of The Medicinal Product

Brevoxyl 4% Cream

2. Qualitative And Quantitative Composition

Benzoyl peroxide 4%w/w as hydrous benzoyl peroxide Ph Eur

100g cream contains 4g benzoyl peroxide.

For excipients, see section 6.1

3. Pharmaceutical Form

Cream

A white to off white cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Brevoxyl is indicated for the treatment of moderate acne vulgaris.

4.2 Posology And Method Of Administration

Adolescents and Adults:

Apply to the whole of the affected area once or twice daily. Wash with soap and water prior to application.

Paediatric use:

The safety and efficacy of Brevoxyl has not been established in children since acne vulgaris rarely presents in this age group.

Initial application of the product may be varied at the physicians instructions to reflect the patients skin type and to avoid undesirable effects.

Improvement can generally be seen after 4-6 weeks of treatment. However, longer use may be necessary.

4.3 Contraindications

Patients with known hypersensitivity to any of the ingredients should not use the product.

4.4 Special Warnings And Precautions For Use

Avoid contact with the eyes, mouth and other mucous membranes. Care should be taken when applying the product to the neck and other sensitive areas. Propylene glycol alginate may cause skin irritation. Stearyl alcohol and cetyl alcohol may cause local skin reaction (e.g. contact dermatitis).

It is recommended that exposure to sun or sunlamps should be minimised.

Simultaneous use of other keratolytics such as salicylates or sulphur may increase occurrence of skin irritation.

During the first weeks of treatment, a sudden increase in peeling and reddening will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued.

The product may bleach hair and coloured or dyed fabrics.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Simultaneous application of Brevoxyl and topical acne preparations containing vitamin A derivatives should be avoided.

4.6 Pregnancy And Lactation

The safety of Brevoxyl in human pregnancy is not established. During pregnancy and lactation Brevoxyl should be used only with special caution and after the physician's assessment of benefit and risk. In the last month of pregnancy Brevoxyl should not be used.

There is no knowledge about the excretion of Brevoxyl in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first few weeks of treatment, a sudden increase in peeling and reddening will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued. The patient may also experience temporary pruritus, facial oedema, dermatitis or rash. As for other benzoyl peroxide preparations allergic contact dermatitis could occasionally occur.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: D10A E01

Benzoyl peroxide is keratolytic and is an oxidising agent with antibacterial activity against Propionibacterium acnes, the organism implicated in acne vulgaris. It has keratolytic activity and is sebostatic, counteracting the hyperkeratinisation and excessive sebum production associated with acne.

5.2 Pharmacokinetic Properties

After topical application, benzoyl peroxide is absorbed in varying quantities through the skin of man and animals.

Radio-labelled studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid. Benzoic acid is mostly conjugated to form hippuric acid which is excreted via the kidneys.

5.3 Preclinical Safety Data

Animal toxicity studies of benzoyl peroxide have shown that the compound is non-toxic when applied topically.

Benzoic acid, to which benzoyl peroxide is converted prior to absorption, has a wide margin of safety. Benzoic acid is an approved food additive.

Benzoyl peroxide is a free radical generating compound. The release of oxygen during its conversion to benzoic acid may be implicated in a tumour promoting effect seen in mouse skin.

Benzoyl peroxide at high doses (>20 times the normal human dose) has been shown to increase tumour growth initiated by dimethyl benzanthracene (DMBA) in mice. DMBA is a powerful chemical carcinogen to which patients are unlikely to be exposed. The relevance of these results to man is limited. Studies in mice have also shown that benzoyl peroxide does not increase the growth of tumours initiated by ultra violet light.

No reproductive toxicology studies have been performed. Up to date there are no indications that the topical use of Brevoxyl causes damage to the unborn child.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Cetyl alcohol

Promulgen G (Stearyl alcohol and Macrogol cetostearyl ether)

Simethicone emulsion

Propylene glycol alginate

Dimethyl isosorbide

Fragrance X-23304

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

18 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Lacquered aluminium or laminated (aluminium/plastic) tubes with white polypropylene screw caps.

Licensed pack sizes: 6g, 40g and 50g.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Administrative Data

7. Marketing Authorisation Holder

Stiefel Laboratories (UK) Ltd

Eurasia Headquarters

Concorde Road

Maidenhead

SL6 4BY

8. Marketing Authorisation Number(S)

PL 00174/0193

9. Date Of First Authorisation/Renewal Of The Authorisation

29 May 1996/ 28 May 2006

10. Date Of Revision Of The Text

July 2010